Study Evaluating ABT-199 in Participants With Relapsed or... | NCT01794520 | Trialant
NCT01794520
Sponsor
AbbVie
Status
Completed
Last Update Posted
Apr 10, 2023Actual
Enrollment
117Actual
Phase
Phase 1Phase 2
Conditions
Relapsed/Refractory Multiple Myeloma
Interventions
Venetoclax
Dexamethasone
Countries
United States
Belgium
France
Norway
Protocol Section
Identification Module
NCT ID
NCT01794520
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M13-367
Secondary IDs
ID
Type
Description
Link
2012-000589-38
EudraCT Number
Brief Title
Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase 1/2 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Mar 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03123029Available
Start Date
Oct 10, 2012Actual
Primary Completion Date
Nov 29, 2021Actual
Completion Date
Nov 29, 2021Actual
First Submitted Date
Oct 12, 2012
First Submission Date that Met QC Criteria
Feb 15, 2013
First Posted Date
Feb 20, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 2, 2022
Results First Submitted that Met QC Criteria
Mar 16, 2023
Results First Posted Date
Apr 10, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 16, 2023
Last Update Posted Date
Apr 10, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Name
Class
Genentech, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study also assessed the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma.
The Phase 2 primary objective was to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.
Detailed Description
Not provided
Conditions Module
Conditions
Relapsed/Refractory Multiple Myeloma
Keywords
Relapsed multiple myeloma
Refractory multiple myeloma
Multiple myeloma
Relapsed/refractory multiple myeloma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
117Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1: Venetoclax 300 mg
Experimental
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Drug: Venetoclax
Phase 1: Venetoclax 600 mg
Experimental
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Drug: Venetoclax
Phase 1: Venetoclax 900 mg
Experimental
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Drug: Venetoclax
Phase 1: Venetoclax 1200 mg
Experimental
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Drug: Venetoclax
Phase 1 Safety Expansion: Venetoclax 1200 mg
Experimental
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Venetoclax
Drug
Each dose of venetoclax was to be taken with approximately 240 mL of water. On days that pre-dose pharmacokinetic (PK) sampling was required, dosing was to occur in the morning at the clinic at approximately 0900 (± 1 hour) to facilitate PK sampling. Dose Escalation cohort participants were to take venetoclax within 30 minutes after the completion of a standard low-fat breakfast with approximately 240 mL of water on Cycle 2 Day 1. On all other dosing days, participants were instructed to take venetoclax orally QD within 30 minutes after the completion of a low-fat breakfast. Tablets were to be swallowed whole and must not have been broken, chewed, or crushed.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
From first dose of study drug until 30 days following last dose of study drug (up to 2482 days)
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Venetoclax
Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
Tmax is the the time at which the maximum plasma concentration (Cmax) is observed.
Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose
Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax
AUC is a measure of how long and how much drug is present in the body after dosing.
Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose (dose escalation cohort); (1200 mg dose): Cycle 2, Day 1 at predose (safety expansion cohort, 1200 mg dose)
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: Overall Response Rate
Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per 2011 International Myeloma Working Group (IMWG) criteria.
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 8.1 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
ECOG (Eastern Cooperative Oncology Group) performance score of 1 or 0. Participants in the Phase 2 portion: ECOG performance score of 2, 1, or 0.
Diagnosis of multiple myeloma (MM) previously treated with at least one prior line of therapy.
Induction therapy followed by stem cell transplant and maintenance therapy will be considered a single line of therapy.
For Safety Expansion, participants must have been previously treated with a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory agent (e.g., thalidomide, lenalidomide).
For Venetoclax-Dexamethasone Combination, participants must have been previously treated with a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory agent (e.g., thalidomide, lenalidomide) AND have t(11;14)-positive multiple myeloma per the central lab testing.
For Phase 2, participants must have MM positive for the t(11;14) translocation, as determined by an analytically validated fluorescence in situ hybridization (FISH) assay per the central laboratory testing (enrollment with local t(11;14)-positive FISH results only will be considered at the discretion of the Therapeutic Area MD). Participants must have evidence of disease progression on or within 60 days of last dose of most recent previous treatment based on International Myeloma Working Group (IMWG) criteria AND must have previously received at least 2 lines of therapy, including an immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor (bortezomib, carfilzomib or ixazomib), daratumumab, and glucocorticoids.
For US participants: Daratumumab combination regimen must be one of the prior lines of therapy (for this study, daratumumab plus corticosteroids will not be considered a combination regimen).
For Non-US participants: Either daratumumab monotherapy or combination therapy is acceptable. Daratumumab monotherapy will be limited to approximately 20 percent of the total number of Phase 2 participants.
Measurable disease at Screening:
Serum monoclonal protein of at least 1.0 g/dL (10g/L) by protein electrophoresis.
At least 200 mg of monoclonal protein in the urine on 24-hr electrophoresis.
Serum immunoglobulin free light chain of at least 10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio.
Participants with a history of autologous or allogenic stem cell transplantation must have adequate peripheral blood counts independent of any growth factor support, and have recovered from any transplant related toxicity(s) and be:
At least 100 days post-autologous transplant prior to first dose of study drug or
At least 6 months post-allogenic transplant prior to first dose of study drug and not have active graft-versus-host disease (GVHD), i.e., requiring treatment.
Meet the following laboratory parameters, per the reference range, at least once during the screening period:
Absolute Neutrophil Count (ANC) of at least 1000/μL (Participants may use growth factor support to achieve ANC eligibility criteria).
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) not higher than 3 x Upper Limit of Normal Range (ULN).
Calculated creatinine clearance of at least 30 mL/min using a modified Cockcroft-Gault calculation.
Platelet count of at least 30,000 mm³ (independent of transfusion for 2 weeks).
Hemoglobin of at least 8.0 g/dL (participants may receive blood transfusion to achieve hemoglobin eligibility criteria).
Total bilirubin not higher than 1.5 x ULN (Participants with Gilbert's Syndrome may have bilirubin higher than 1.5 x ULN).
Exclusion Criteria:
Exhibits evidence of other clinically significant uncontrolled condition(s), including, but not limited to:
Acute infection within 14 days prior to first dose of study drug requiring antibiotic, antifungal, or antiviral therapy.
Diagnosis of fever and neutropenia within 1 week prior to first dose of study drug.
Cardiovascular disability status of New York Heart Association Class ≥ 3.
Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular or hepatic disease, within the last 6 months that, in the opinion of the investigator, would adversely affect his/her participation in the study.
History of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions:
Adequately treated in situ carcinoma of the cervix uteri;
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
Localized prostate cancer Gleason grade 6 or lower AND with stable prostate specific antigen (PSA) levels off treatment
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Known Human Immunodeficiency Viral (HIV) infection.
Active hepatitis B or C infection.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Mayo Clinic - Scottsdale /ID# 75808
Scottsdale
Arizona
85259-5452
United States
University of Arkansas for Medical Sciences /ID# 170002
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
FG001
Phase 1: Venetoclax 600 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 17, 2021
Nov 2, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Venetoclax
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Experimental
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Drug: Venetoclax
Drug: Dexamethasone
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Experimental
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Drug: Venetoclax
Drug: Dexamethasone
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Phase 1 Safety Expansion: Venetoclax 1200 mg
Phase 1: Venetoclax 1200 mg
Phase 1: Venetoclax 300 mg
Phase 1: Venetoclax 600 mg
Phase 1: Venetoclax 900 mg
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
ABT-199
VENCLEXTA®
Dexamethasone
Drug
Tablets were administered by mouth per the dexamethasone prescribing information.
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Phase 2: Overall Response Rate
Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria.
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 months
Phase 2: Very Good Partial Response Rate or Better
The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria was computed.
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 months
Time to Response (TTR)
TTR is defined as the number of days from the date of first dose of study drug until the date of their first favorable response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per 2011 International Myeloma Working Group (IMWG) criteria (Phase 1) or 2016 IMWG criteria (Phase 2). If a participant did not experience a favorable response, they were to be censored at the date of last adequate assessment. TTR was analyzed by Kaplan- Meier (K-M)\ methodology.
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; Estimated median time on follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2
Time to Progression (TTP)
TTP is defined as the number of days from the date of first dose of study drug to the date of first documented disease progression or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan- Meier (K-M) methodology.
Estimated median duration of follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2
Duration of Response
DOR is defined as the number of days from the date of first response of Partial Response (PR) or better to the date of first documented disease progression or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan- Meier (K-M) methodology.
Assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median duration of follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2
Phase 2: Progression-Free Survival (PFS)
PFS is defined as the number of days from the date of the first dose of study treatment to the date of first documented disease progression or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.
Estimated median duration of follow-up was 31.7 months
Phase 2: Overall Survival (OS)
OS is defined as the number of days from the date of the first dose of study drug to the date of death due to any cause. If a participant was not known to have died, OS was censored at the last known alive date. The distribution of OS was estimated using Kaplan-Meier methodology.
Estimated median duration of follow-up was 31.7 months
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement.
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The [PROMIS] Cancer Fatigue Short Form [SF] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
Little Rock
Arkansas
72205
United States
Yale University /ID# 203704
New Haven
Connecticut
06510
United States
Emory University, Winship Cancer Institute /ID# 74993
Atlanta
Georgia
30322
United States
Ingalls Memorial Hosp /ID# 205346
Harvey
Illinois
60426
United States
Tulane Cancer Center Clinic /ID# 204123
New Orleans
Louisiana
70112
United States
Tufts Medical Center /ID# 203814
Boston
Massachusetts
02111-1552
United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 170007
Ann Arbor
Michigan
48109
United States
Mayo Clinic - Rochester /ID# 74994
Rochester
Minnesota
55905-0001
United States
Hattiesburg Clinic /ID# 201187
Hattiesburg
Mississippi
39401
United States
Washington University-School of Medicine /ID# 76094
St Louis
Missouri
63110
United States
University of Nebraska Medical Center /ID# 169158
Omaha
Nebraska
68198-6840
United States
The John Theurer Cancer /ID# 200248
Hackensack
New Jersey
07601
United States
Duke Cancer Center /ID# 129356
Durham
North Carolina
27710-3000
United States
University Hospitals - Seidman Cancer Center /ID# 204502
Kumar S, Kaufman JL, Gasparetto C, Mikhael J, Vij R, Pegourie B, Benboubker L, Facon T, Amiot M, Moreau P, Punnoose EA, Alzate S, Dunbar M, Xu T, Agarwal SK, Enschede SH, Leverson JD, Ross JA, Maciag PC, Verdugo M, Touzeau C. Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma. Blood. 2017 Nov 30;130(22):2401-2409. doi: 10.1182/blood-2017-06-788786. Epub 2017 Oct 10.
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
FG002
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
FG003
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
FG004
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
FG005
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
FG006
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
FG0006 subjects
FG0019 subjects
FG0026 subjects
FG0039 subjects
FG00436 subjects
FG00520 subjects
FG00631 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0006 subjects
FG0019 subjects
FG0026 subjects
FG0039 subjects
FG00436 subjects
FG00520 subjects
FG00631 subjects
Type
Comment
Reasons
Adverse events- related to progression
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Adverse event- not related to progression
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive disease
FG0005 subjects
FG0016 subjects
FG0022 subjects
FG0035 subjects
FG004
Withdrew consent
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Toxicity
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other, not specified
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
BG001
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
BG002
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
BG003
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
BG004
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
BG005
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
BG006
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0019
BG0026
BG0039
BG00436
BG00520
BG00631
BG007117
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00062.0± 7.32
BG00163.1± 9.03
BG00261.8± 12.06
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
White
Title
Measurements
BG0006
BG0019
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Safety population: all participants who received at least one dose of study drug
Posted
Count of Participants
Participants
No
From first dose of study drug until 30 days following last dose of study drug (up to 2482 days)
ID
Title
Description
OG000
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG001
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG002
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG003
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG004
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG005
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
OG006
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Units
Counts
Participants
OG0006
OG0019
OG0026
OG003
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG0006
OG0019
OG0026
OG003
Primary
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Venetoclax
Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Phase 1 dose escalation and safety expansion participants with available data
Posted
Mean
Standard Deviation
µg/mL
Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose
ID
Title
Description
OG000
300 mg Venetoclax
Participants who received a 300 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
OG001
600 mg Venetoclax
Participants who received a 600 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
OG002
900 mg Venetoclax
Participants who received a 900 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
OG003
1200 mg Venetoclax
Participants who received a 1200 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
Primary
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
Tmax is the the time at which the maximum plasma concentration (Cmax) is observed.
Phase 1 dose escalation and safety expansion participants with available data
Posted
Median
Full Range
hours
Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose
ID
Title
Description
OG000
300 mg Venetoclax
Participants who received a 300 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
OG001
600 mg Venetoclax
Participants who received a 600 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
OG002
900 mg Venetoclax
Participants who received a 900 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
OG003
1200 mg Venetoclax
Participants who received a 1200 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
Primary
Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax
AUC is a measure of how long and how much drug is present in the body after dosing.
Phase 1 dose escalation and safety expansion participants with available data
Posted
Mean
Standard Deviation
µg•h/mL
Cycle 2, Day 1 at predose, 2, 4, 6, 8, and 24 hours postdose (dose escalation cohort); (1200 mg dose): Cycle 2, Day 1 at predose (safety expansion cohort, 1200 mg dose)
ID
Title
Description
OG000
300 mg Venetoclax
Participants who received a 300 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
OG001
600 mg Venetoclax
Participants who received a 600 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
OG002
900 mg Venetoclax
Participants who received a 900 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
OG003
1200 mg Venetoclax
Primary
Phase 2: Overall Response Rate
Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria.
All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; primary efficacy endpoints were pre-specified for Phase 2 only, and are reported for all participants with available data
Posted
Number
95% Confidence Interval
percentage of participants
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 months
ID
Title
Description
OG000
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Units
Counts
Participants
Primary
Phase 2: Very Good Partial Response Rate or Better
The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria was computed.
All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; primary efficacy endpoints were pre-specified for Phase 2 only, and are reported for all participants with available data
Posted
Number
95% Confidence Interval
percentage of participants
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 months
ID
Title
Description
OG000
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Units
Counts
Participants
Secondary
Phase 1: Overall Response Rate
Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per 2011 International Myeloma Working Group (IMWG) criteria.
All enrolled Phase 1 participants who had active disease at baseline and received venetoclax
Posted
Number
95% Confidence Interval
percentage of participants
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 8.1 months
ID
Title
Description
OG000
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG001
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG002
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Secondary
Time to Response (TTR)
TTR is defined as the number of days from the date of first dose of study drug until the date of their first favorable response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per 2011 International Myeloma Working Group (IMWG) criteria (Phase 1) or 2016 IMWG criteria (Phase 2). If a participant did not experience a favorable response, they were to be censored at the date of last adequate assessment. TTR was analyzed by Kaplan- Meier (K-M)\ methodology.
All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response (PR or better)
Posted
Median
95% Confidence Interval
months
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; Estimated median time on follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2
ID
Title
Description
OG000
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG001
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Secondary
Time to Progression (TTP)
TTP is defined as the number of days from the date of first dose of study drug to the date of first documented disease progression or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan- Meier (K-M) methodology.
All enrolled participants who received venetoclax
Posted
Median
95% Confidence Interval
months
Estimated median duration of follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2
ID
Title
Description
OG000
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG001
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG002
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Secondary
Duration of Response
DOR is defined as the number of days from the date of first response of Partial Response (PR) or better to the date of first documented disease progression or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan- Meier (K-M) methodology.
All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response of PR or better
Posted
Median
95% Confidence Interval
months
Assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median duration of follow-up was 8.1 months for Phase 1 and 31.7 months for Phase 2
ID
Title
Description
OG000
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG001
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG002
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
Secondary
Phase 2: Progression-Free Survival (PFS)
PFS is defined as the number of days from the date of the first dose of study treatment to the date of first documented disease progression or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.
All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; this endpoint was pre-specified for Phase 2 only, data are reported for all participants with available data
Posted
Median
95% Confidence Interval
months
Estimated median duration of follow-up was 31.7 months
ID
Title
Description
OG000
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Units
Counts
Participants
OG000
Secondary
Phase 2: Overall Survival (OS)
OS is defined as the number of days from the date of the first dose of study drug to the date of death due to any cause. If a participant was not known to have died, OS was censored at the last known alive date. The distribution of OS was estimated using Kaplan-Meier methodology.
All enrolled Phase 2 participants who received venetoclax; this endpoint was pre-specified for Phase 2 only, data are reported for all participants with available data
Posted
Median
95% Confidence Interval
months
Estimated median duration of follow-up was 31.7 months
ID
Title
Description
OG000
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Units
Counts
Participants
OG000
Secondary
Phase 2: Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.
Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
Posted
Mean
Standard Deviation
units on a scale
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
ID
Title
Description
OG000
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Secondary
Phase 2: Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement.
Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
Posted
Mean
Standard Deviation
units on a scale
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
ID
Title
Description
OG000
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Secondary
Phase 2: Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.
Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
Posted
Mean
Standard Deviation
units on a scale
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
ID
Title
Description
OG000
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Secondary
Phase 2: Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The [PROMIS] Cancer Fatigue Short Form [SF] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.
Intent-to-Treat (ITT) population: all participants who received at least one dose of study drug; participants who have both baseline and post-baseline values are included in the analysis at each visit
Posted
Mean
Standard Deviation
T-score
Baseline; Cycle 3, Day 1; Cycle 5, Day 1; Cycle 7, Day 1; Cycle 9, Day 1; Cycle 11, Day 1; Cycle 13, Day 1; Cycle 15, Day 1; Cycle 17, Day 1; Cycle 19, Day 1; Cycle 21, Day 1; Cycle 23, Day 1; Cycle 25, Day 1; Final visit
ID
Title
Description
OG000
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Time Frame
All-cause mortality is reported from enrollment to end of study; median time on follow up was 6.6, 3.4, 3.8, 3.0, 11.0, 13.2, and 31.7 months for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
Description
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 171.8, 283.1, 474.5, 76.4, 315.4, 400.0, and 240.3 days for Phase 1 300 mg Ven, Phase 1 600 mg Ven, Phase 1 900 mg Ven, Phase 1 1200 mg Ven, Phase 1 Safety Expansion Ven 1200 mg, Phase 1 Combination Ven 800 mg/Dex, and Phase 2 Expansion Ven 800 mg/Dex, respectively.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 1: Venetoclax 300 mg
Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
1
6
1
6
6
6
EG001
Phase 1: Venetoclax 600 mg
Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
1
9
4
9
9
9
EG002
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
1
6
3
6
6
6
EG003
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
0
9
3
9
9
9
EG004
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
6
36
15
36
35
36
EG005
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
1
20
6
20
19
20
EG006
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
22
31
16
31
27
31
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected9 at risk
EG0041 events1 affected36 at risk
EG0051 events1 affected20 at risk
EG0060 events0 affected31 at risk
HYPERVISCOSITY SYNDROME
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
OESOPHAGITIS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CHEST PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PYREXIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ANAPHYLACTIC REACTION
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ABSCESS BACTERIAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ABSCESS INTESTINAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CANDIDA INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CLOSTRIDIUM DIFFICILE COLITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CLOSTRIDIUM DIFFICILE INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DIVERTICULITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ENTEROBACTER SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ENTEROCOCCAL SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ENTEROVIRUS INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ESCHERICHIA SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
LISTERIA SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
LOCALISED INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PARAINFLUENZAE VIRUS INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PNEUMONIA ASPIRATION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PNEUMONIA INFLUENZAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PNEUMONIA KLEBSIELLA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PNEUMONIA STREPTOCOCCAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
RHINOVIRUS INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
STREPTOCOCCAL SEPSIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CLAVICLE FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
RIB FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
TUMOUR LYSIS SYNDROME
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
LUMBAR SPINAL STENOSIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CHRONIC MYELOMONOCYTIC LEUKAEMIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
MALIGNANT NEOPLASM PROGRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
CEREBRAL HAEMORRHAGE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
BENIGN PROSTATIC HYPERPLASIA
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
THROMBOSIS
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0013 events3 affected9 at risk
EG0021 events1 affected6 at risk
EG0033 events3 affected9 at risk
EG0045 events5 affected36 at risk
EG0052 events2 affected20 at risk
EG0069 events7 affected31 at risk
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
LYMPHOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0023 events2 affected6 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0016 events4 affected9 at risk
EG0022 events1 affected6 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CATARACT
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
EYE DISCHARGE
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
EYE PAIN
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
VISUAL ACUITY REDUCED
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected6 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected6 at risk
EG003
DENTAL CARIES
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0015 events4 affected9 at risk
EG0025 events2 affected6 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0017 events6 affected9 at risk
EG0023 events3 affected6 at risk
EG003
ODYNOPHAGIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PARAESTHESIA ORAL
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected6 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
TRICHOGLOSSIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
UMBILICAL HERNIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0016 events4 affected9 at risk
EG0022 events2 affected6 at risk
EG003
ASTHENIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected6 at risk
EG003
CHILLS
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
FACE OEDEMA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
FATIGUE
General disorders
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
FEELING COLD
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
MALAISE
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
OEDEMA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PYREXIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected9 at risk
EG0020 events0 affected6 at risk
EG003
BRONCHITIS VIRAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CLOSTRIDIUM DIFFICILE COLITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CONJUNCTIVITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CYSTITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
LOCALISED INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected6 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PARAINFLUENZAE VIRUS INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
RHINITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
RHINOVIRUS INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
TOOTH INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ANKLE FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DENTAL RESTORATION FAILURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HEAD INJURY
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
POST PROCEDURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
SKIN LACERATION
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
TONGUE INJURY
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ACTIVATED PARTIAL THROMBOPLASTIN TIME ABNORMAL
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0022 events1 affected6 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD LACTATE DEHYDROGENASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD PHOSPHORUS INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
BLOOD THYROID STIMULATING HORMONE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
CARDIAC MURMUR
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
INTRAOCULAR PRESSURE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
LIPASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NEUTROPHIL COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected6 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events3 affected9 at risk
EG0022 events1 affected6 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
DIABETES MELLITUS INADEQUATE CONTROL
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERNATRAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERURICAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected9 at risk
EG0022 events1 affected6 at risk
EG003
MALNUTRITION
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
STEROID DIABETES
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0012 events2 affected9 at risk
EG0022 events1 affected6 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
EXOSTOSIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected9 at risk
EG0022 events1 affected6 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected6 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
OSTEONECROSIS OF JAW
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected6 at risk
EG003
SPINAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
TENDONITIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
MALIGNANT MELANOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PANCREATIC NEUROENDOCRINE TUMOUR
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SQUAMOUS CELL CARCINOMA OF SKIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
COGNITIVE DISORDER
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0023 events3 affected6 at risk
EG003
DYSAESTHESIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HEAD DISCOMFORT
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected6 at risk
EG003
HEMIPARESIS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERSOMNIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PARAESTHESIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
AGITATION
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
MOOD ALTERED
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ERECTILE DYSFUNCTION
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0013 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0004 events2 affected6 at risk
EG0011 events1 affected9 at risk
EG0022 events2 affected6 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SNEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
UPPER-AIRWAY COUGH SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
ACTINIC KERATOSIS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERKERATOSIS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PAIN OF SKIN
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PAPULE
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected6 at risk
EG003
PURPURA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected9 at risk
EG0020 events0 affected6 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SKIN ATROPHY
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
EMBOLISM
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected6 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
9
OG00436
OG00520
OG00631
9
OG00436
OG00519
OG00630
TESAE
Title
Measurements
OG0001
OG0014
OG0023
OG0033
OG00415
OG0056
OG00616
Units
Counts
Participants
OG0006
OG0015
OG0024
OG00312
Title
Denominators
Categories
Title
Measurements
OG0000.897± 0.593
OG0012.56± 1.77
OG0021.85± 1.30
OG0034.16± 1.52
Units
Counts
Participants
OG0006
OG0015
OG0024
OG00312
Title
Denominators
Categories
Title
Measurements
OG0005.0(2.0 to 8.0)
OG0018.0(2.7 to 8.0)
OG0026.0(4.0 to 8.0)
OG0036.1(4.0 to 8.0)
Participants who received a 1200 mg dose of venetoclax administered on the intensive pharmacokinetic sampling day
Units
Counts
Participants
OG0006
OG0015
OG0023
OG0039
Title
Denominators
Categories
Title
Measurements
OG00013.0± 8.31
OG00138.2± 25.1
OG00226.3± 20.1
OG00371.5± 35.8
OG00031
Title
Denominators
Categories
Title
Measurements
OG00048.4(30.2 to 66.9)
OG00031
Title
Denominators
Categories
Title
Measurements
OG00035.5(19.2 to 54.6)
OG003
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG004
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG005
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Units
Counts
Participants
OG0006
OG0019
OG0026
OG0039
OG00436
OG00520
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 45.9)
OG00111.1(0.3 to 48.2)
OG00216.7(0.4 to 64.1)
OG0030(0.0 to 33.6)
OG00436.1(20.8 to 53.8)
OG00565.0(40.8 to 84.6)
OG002
Phase 1: Venetoclax 900 mg
Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG003
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG004
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG005
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
OG006
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Units
Counts
Participants
OG0000
OG0011
OG0021
OG0030
OG00413
OG00513
OG00615
Title
Denominators
Categories
Title
Measurements
OG001NA(1.9 to NA)Not estimable/calculable due to low number of participants with events
OG002NA(1.2 to NA)Not estimable/calculable due to low number of participants with events
OG0049.0(1.9 to NA)Not estimable/calculable due to low number of participants with events
OG0052.6(1.4 to NA)Not estimable/calculable due to low number of participants with events
OG0060.8(0.7 to NA)Not estimable/calculable due to low number of participants with events
OG003
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG004
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG005
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
OG006
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Units
Counts
Participants
OG0006
OG0019
OG0026
OG0039
OG00436
OG00520
OG00631
Title
Denominators
Categories
Title
Measurements
OG0005.0(3.9 to NA)Not estimable/calculable due to low number of participants with events
OG0012.0(0.5 to NA)Not estimable/calculable due to low number of participants with events
OG0021.2(0.4 to NA)Not estimable/calculable due to low number of participants with events
OG0031.9(0.5 to NA)Not estimable/calculable due to low number of participants with events
OG0044.2(1.9 to 10.2)
OG00512.2(4.2 to 20.9)
OG00611.2(5.2 to 18.4)
OG003
Phase 1: Venetoclax 1200 mg
Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG004
Phase 1 Safety Expansion: Venetoclax 1200 mg
Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
OG005
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
Participants with t(11;14) translocation multiple myeloma received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
OG006
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
Units
Counts
Participants
OG0000
OG0011
OG0021
OG0030
OG00413
OG00513
OG00615
Title
Denominators
Categories
Title
Measurements
OG0019.7(NA to NA)Not estimable/calculable due to low number of participants with events
OG002NA(NA to NA)Not estimable/calculable due to low number of participants with events